Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

Hypertension Clinical Trial

— SMAL-SALT  

Official title:

Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04286802
• Other study ID #: 04-60-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.

Description:

A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)

• Diagnosed of hypertension for at least 3 months

• No adjustment of antihypertensive agents for at least 1 month

• 24h Urine sodium = 90 mmol/day

• eGFR = 45 ml/min/1.73 sq.m.

Exclusion Criteria:

• eGFR < 45 ml/min/1.73 sq.m.

• UACR > 300 mg/g

• Serum potassium > 6.0 mmol/l

• Serum sodium < 135 mmol/l

• Unable to collect 24-hour urine

Related Conditions & MeSH terms

• Hypertension
• Salt; Excess

Intervention

Device:
• Salt-meter
Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.

Behavioral:
• Education
Program dietary education by certified dietician who did not know the patients arm allocation.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Cook NR, Kumanyika SK, Cutler JA, Whelton PK; Trials of Hypertension Prevention Collaborative Research Group. Dose-response of sodium excretion and blood pressure change among overweight, nonhypertensive adults in a 3-year dietary intervention study. J Hum Hypertens. 2005 Jan;19(1):47-54. — View Citation

Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10. — View Citation

MacGregor GA, Markandu ND, Sagnella GA, Singer DR, Cappuccio FP. Double-blind study of three sodium intakes and long-term effects of sodium restriction in essential hypertension. Lancet. 1989 Nov 25;2(8674):1244-7. — View Citation

Mente A, O'Donnell MJ, Rangarajan S, McQueen MJ, Poirier P, Wielgosz A, Morrison H, Li W, Wang X, Di C, Mony P, Devanath A, Rosengren A, Oguz A, Zatonska K, Yusufali AH, Lopez-Jaramillo P, Avezum A, Ismail N, Lanas F, Puoane T, Diaz R, Kelishadi R, Iqbal R, Yusuf R, Chifamba J, Khatib R, Teo K, Yusuf S; PURE Investigators. Association of urinary sodium and potassium excretion with blood pressure. N Engl J Med. 2014 Aug 14;371(7):601-11. doi: 10.1056/NEJMoa1311989. — View Citation

Piovesana Pde M, Sampaio Kde L, Gallani MC. Association between Taste Sensitivity and Self-Reported and Objective Measures of Salt Intake among Hypertensive and Normotensive Individuals. ISRN Nutr. 2012 Oct 24;2013:301213. doi: 10.5402/2013/301213. eCollection 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with hypertensive emergency	Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents.	8 weeks
Other	Questionnaire about motivation to maintain low salt diet	Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks	after 8 weeks
Primary	24-hour urinary sodium excretion	Change in 24-hour urinary sodium excretion from baseline	8 weeks
Secondary	Change in systolic and diastolic blood pressure	Changes in systolic and diastolic blood pressure from baseline	8 weeks
Secondary	Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds	Using the different saline concentration in solution. Starting from the lowest to higher concentration, the point when the patient can differentiate from distilled water is called "detection threshold", and the point that patient can identify salty taste is called "recognition" threshold.	8 weeks
Secondary	Change in cardio-ankle vascular index (CAVI)	Change in cardio-ankle vascular index (CAVI) from baseline	8 weeks